To Assess the Safety and Efficacy of R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:18 - 85
Updated:5/5/2014
Start Date:July 2013
End Date:July 2014
Contact:Daniel Magilavy, MD
Email:DMagilavy@Rigel.com
Phone:650-624-1372

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A Phase 2, Multi-Center, Randomized, Double-Masked, Placebo-Controlled Clinical Study to Assess the Safety and Efficacy of 0.2% and 0.5% R932348 Ophthalmic Solutions in Patients With Keratoconjunctivitis Sicca

The purpose of this study is to determine whether 0.2% and 0.5% R348 Ophthalmic Solutions
are safe and effective in the treatment of Patients with Keratoconjunctivitis Sicca.


Inclusion Criteria:

- A history of dry eye (based on the date of initial dry eye symptoms)

- Use of over-the-counter (OTC) and/or prescription eye drops for dry eye symptoms

- Corneal fluorescein staining score of at least 2 in the inferior region

Exclusion Criteria:

- History of, or a concurrent clinically significant illness, medical condition (other
than Keratoconjunctivitis Sicca or Sjögren's syndrome), or laboratory abnormality
that, in the Investigator's opinion, could affect the conduct of the study.

- Use of ophthalmic cyclosporine within 45 days of Visit 1.

- Use of any topical ophthalmic steroid within 2 weeks of Visit 1.

- Have worn contact lenses or anticipate using contact lenses during the study.

- Have a condition or be in a situation that the Investigator feels may put the subject
at significant risk, may confound the study results, or may interfere significantly
with the subject's participation in the study.

- Have a history of alcohol or substance abuse that, in the judgment of the
Investigator, may impair or risk the subject's full participation in the study.
We found this trial at
20
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Charlotte, North Carolina
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Artesia, California 90701
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Brandon, Florida 33603
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Charlotte, North Carolina 28210
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Chattanooga, Tennessee 37411
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Chicago, Illinois 60634
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Cleveland, Ohio 44115
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High Point, North Carolina 27262
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Hoffman Estates, Illinois
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Lebanon, Kentucky 40033
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Louisville, Kentucky 40217
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Morrow, Georgia 30260
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Mt. Pleasant, South Carolina 29464
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Parker, Colorado 80813
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Petaluma, California 94954
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Rancho Cardova, California 95670
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Roswell, Georgia 30076
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San Antonio, Texas 78209
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Stuart, Florida 34994
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